首页> Regenerative therapy> Multisite studies for optimization of a highly efficient culture assay used for <i>in vitro</i> detection of residual undifferentiated human pluripotent stem cells intermingled in cell therapy products.

Multisite studies for optimization of a highly efficient culture assay used for <i>in vitro</i> detection of residual undifferentiated human pluripotent stem cells intermingled in cell therapy products.

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第一作者： Takeshi,Watanabe

第一单位： Drug Safety Research and Evaluation, Takeda Pharmaceutical Company Limited, Kanagawa, Japan.

作者： Takeshi,Watanabe ^[1] ; Satoshi,Yasuda ^[2] ; Shinji,Kusakawa ^[2] ; Takuya,Kuroda ^[2] ; Hatsue,Furukawa ^[3] ; Mayumi,Futamura ^[4] ; Shigekazu,Shimizu ^[5] ; Akihiko,Morishita ^[6] ; Shinko,Hata ^[6] ; Akiko,Koeda ^[7] ; Kana,Komatsu ^[8] ; Yoji,Sato ^[9]

作者单位： Drug Safety Research and Evaluation, Takeda Pharmaceutical Company Limited, Kanagawa, Japan. ^[1] Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan. ^[2] Safety Business Unit, Axcelead Drug Discovery Partners, Inc., Kanagawa, Japan. ^[3] Drug Discovery Support Division, Tsukuba Research Institute, BoZo Research Center Inc., Ibaraki, Japan. ^[4] CMIC Bioresearch Center, CMIC Pharma Science Co., Ltd., Yamanashi, Japan. ^[5] Ig-M Co. Ltd, Hyogo, Japan. ^[6] Research Administration Department, Ina Research Inc., Nagano, Japan. ^[7] Clinical Laboratory Department, Ina Research Inc., Nagano, Japan. ^[8] Division of Cell-Based Therapeutic Products, National Institute of Health Sciences, Kanagawa, Japan.;Division of Drugs, National Institute of Health Sciences, Kanagawa, Japan. ^[9]

关键词 Cell therapy products Detection sensitivity In?vitro tumorigenicity assay Multisite study Residual pluripotent stem cell Standardization

DOI 10.1016/j.reth.2024.06.007

PMID 38983832

发布时间 2024-07-11

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Regenerative therapy

2024年26卷

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Regenerative therapy

2024年26卷

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Multisite studies for optimization of a highly efficient culture assay used for <i>in vitro</i> detection of residual undifferentiated human pluripotent stem cells intermingled in cell therapy products.

Regenerative therapy

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Multisite studies for optimization of a highly efficient culture assay used for <i>in vitro</i> detection of residual undifferentiated human pluripotent stem cells intermingled in cell therapy products.

Regenerative therapy

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Regenerative therapy

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